BEUDAMED
    12 results · 18ms · Sources: EU EUDAMED, US FDA

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    Sterile Hypodermic Needles for Single Use

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Wrist Lacer II

    FDA UDI
    MEDICAL SPECIALTIES INCORPORATED·00802357233342·

    REPROCESSED STEERABLE INTRODUCER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BMC CATHETER CONNECTOR CABLE, MODEL RFP-101

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RESERVOIR 1.8ML

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·November 4, 2014

    SIMON NITINOL FILTER SYSTEM - FEMORAL

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·August 15, 2011

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 12, 2013

    syngo.via RT Image Suite with syngo.via VB30, VB40, VB50 and VB60- Intended for Radiation Therapy Treatment Material Number: 10496180

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·September 22, 2021

    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

    SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

    FDA Enforcement
    Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018

    Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor

    FDA Enforcement
    Class II ·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025